Not Yet RecruitingEarly Phase 1

CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms

China20 participantsStarted 2026-01-31

Plain-language summary

This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
✓. Clinically diagnosed with high-risk plasma cell neoplasm, meeting any one of the following molecular/cytogenetic or clinical criteria:
✓. Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and/or TP53 gene mutation;
✓. IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and/or deletion of the short arm of chromosome 1 (del(1p32));
✓. Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);
✓. β₂-microglobulin ≥ 5.5 mg/L with normal serum creatinine (\< 1.2 mg/dL).
✓. Age 18 to 75 years (inclusive), male or female.
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

Exclusion criteria

✕. Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) \< 50%.
✕. History of severe chronic lung disease associated with impaired pulmonary function.
✕. Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
✕. Concurrent severe infection that cannot be effectively controlled with standard therapy.
✕. Concurrent severe autoimmune disease or congenital immunodeficiency disorders.
✕. Active viral hepatitis, defined as hepatitis B virus DNA (HBV-DNA) or hepatitis C virus RNA (HCV-RNA) levels above the lower limit of detection (LLOD).
✕. Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
✕. History of severe allergic reactions to biological products, including antibiotics.

What they're measuring

According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.

Timeframe: up to 3 years

According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.

Timeframe: MTD will be determined based on DLTs observed during the first 28 days of study treatment

Trial details

NCT IDNCT07416682

SponsorAffiliated Hospital to Academy of Military Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-30

Contact for this trial

Yamei Wu

+86 01066947164 rippleya@126.com

View on ClinicalTrials.gov More High-risk Plasma Cell Neoplasms trials